CORonary Diet Intervention With Olive Oil and Cardiovascular PREVention (CORDIOPREV)
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|ClinicalTrials.gov Identifier: NCT00924937|
Recruitment Status : Active, not recruiting
First Posted : June 19, 2009
Last Update Posted : March 15, 2018
|Condition or disease||Intervention/treatment||Phase|
|Myocardial Infarction Unstable Angina Malignancy Cognitive Decline Diabetes Mellitus Metabolic Syndrome||Behavioral: Mediterranean Diet Behavioral: Low Fat Diet||Not Applicable|
Randomized clinical trial involving 1002 patients with coronary disease that are undergoing one of two diets in a randomized design (two groups; Mediterranean Diet 502 patients, Low Fat 500 patients) for 7 years. The two diets are: a)Low fat diet: <30% fat (12-14% monounsaturated fatty acids (MUFA); 6-8% polyunsaturated fatty acid (PUFA) ; <10% SAT) and b) Mediterranean Diet: >35% fat (22% MUFA; 6% PUFA ; <10% SAT).
Combined apparition of hard cardiovascular events (myocardial infarction, revascularization, ischemic stroke, documented peripheral artery disease or cardiovascular death).
Those related in the Outcome Measures section of this webpage
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1002 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Randomized Clinical Trial on the Effects of Mediterranean Diet (Rich on Olive Oil) in the Reduction of Coronary Events of Patients With Coronary Disease|
|Actual Study Start Date :||November 2009|
|Estimated Primary Completion Date :||February 2019|
|Estimated Study Completion Date :||September 2019|
Active Comparator: Low Fat Diet
Dietary Intervention with a Low fat diet: <30% fat (12% monounsaturated fatty acids; 6-8%polyunsaturated fatty acids; <10% saturated fatty acids)
Behavioral: Low Fat Diet
Low fat diet: <30% fat (12% MUFA; 6-8%PUFA; <10% SAT)
Experimental: Mediterranean Diet
Dietary Intervention with a Mediterranean Diet: 35-38% fat (22% monounsaturated fatty acids; 6% polyunsaturated fatty acids; <10% saturated fatty acids).
Behavioral: Mediterranean Diet
Mediterranean Diet:35-38% fat (22% MUFA; 6% PUFA; <10% SAT).
- Combined apparition of hard cardiovascular events (myocardial infarction, revascularization, ischemic stroke, documented peripheral artery disease or cardiovascular death) after a median follow-up of 7 years. [ Time Frame: Seven Years ]
- Incidence of intermittent claudication. [ Time Frame: Seven Years ]
- Concentration of LDL cholesterol. [ Time Frame: Seven Years ]
- Atherogenic ratio Total cholesterol/HDL and LDL/HDL. [ Time Frame: Seven Years ]
- Metabolic control of carbohydrates (assessed by glycemic and insulin responses to intravenous tolerance test to glucose). [ Time Frame: Seven Years ]
- Blood pressure. [ Time Frame: Seven Years ]
- Incidence of malignancy. [ Time Frame: Seven Years ]
- Progression of Cognitive Decline. [ Time Frame: Seven Years ]
- Extended composite of cardiovascular disease progression [ Time Frame: Seven Years ]Incidence of cardiac death, myocardial infarction, angina event, coronary revascularization or cardiac transplant, stroke, symptomatic heart failure, or any other clinical manifestation of cardiovascular event.
- Extended composite of heart events [ Time Frame: Seven Years ]Cardiac death , myocardial infarction , unstable angina , revascularization, heart failure, heart transplantation, cardiac arrest
- Incidence of type 2 Diabetes Mellitus [ Time Frame: Up to Seven Years ]
- Incidence of Metabolic Syndrome [ Time Frame: Up to Seven Years ]
- Composition of the different families of Gut Microbiota [ Time Frame: Up to Seven Years ]Changes in the percentage of different families of Microbiota will be analyzed during the study
- Endothelial function (Flow mediated dilation) [ Time Frame: Up to Seven Years ]Endothelium response to ischemia in the brachial artery. Area under the curve, flow peak and time to maximum flow will be performed
- genetics [ Time Frame: Up to seven years ]Influence of genotype in the development of type 2 dm, at 1, 2, 4 and 7 years
- postprandial lipaemia [ Time Frame: Up to seven years ]Influence of metabolic phenotypes and diet on postprandial lipemia
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00924937
|Reina Sofia University Hospital|
|Cordoba, Spain, 14001|
|Principal Investigator:||Francisco Perez-Jimenez, MD,PhD||Reina Sofia University Hospital|